Florida Senate - 2015 COMMITTEE AMENDMENT
Bill No. PCS (592332) for CS for SB 1052
Ì399254>Î399254
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/21/2015 .
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The Committee on Fiscal Policy (Bean) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 499.0295, Florida Statutes, is created
6 to read:
7 499.0295 Experimental treatments for terminal conditions.—
8 (1) This section may be cited as the “Right to Try Act.”
9 (2) As used in this section, the term:
10 (a) “Eligible patient” means a person who:
11 1. Has a terminal condition that is attested to by the
12 patient’s physician and confirmed by a second independent
13 evaluation by a board-certified physician in an appropriate
14 specialty for that condition;
15 2. Has considered all other treatment options for the
16 terminal condition currently approved by the United States Food
17 and Drug Administration;
18 3. Has given written informed consent for the use of an
19 investigational drug, biological product, or device; and
20 4. Has documentation from his or her treating physician
21 that the patient meets the requirements of this paragraph.
22 (b) “Investigational drug, biological product, or device”
23 means a drug, biological product, or device that has
24 successfully completed phase 1 of a clinical trial but has not
25 been approved for general use by the United States Food and Drug
26 Administration and remains under investigation in a clinical
27 trial approved by the United States Food and Drug
28 Administration.
29 (c) “Terminal condition” means a progressive disease or
30 medical or surgical condition that causes significant functional
31 impairment, is not considered by a treating physician to be
32 reversible even with the administration of available treatment
33 options currently approved by the United States Food and Drug
34 Administration, and, without the administration of life
35 sustaining procedures, will result in death within 1 year after
36 diagnosis if the condition runs its normal course.
37 (d) “Written informed consent” means a document that is
38 signed by a patient, a parent of a minor patient, a court
39 appointed guardian for a patient, or a health care surrogate
40 designated by a patient and includes:
41 1. An explanation of the currently approved products and
42 treatments for the patient’s terminal condition.
43 2. An attestation that the patient concurs with his or her
44 physician in believing that all currently approved products and
45 treatments are unlikely to prolong the patient’s life.
46 3. Identification of the specific investigational drug,
47 biological product, or device that the patient is seeking to
48 use.
49 4. A realistic description of the most likely outcomes of
50 using the investigational drug, biological product, or device.
51 The description shall include the possibility that new,
52 unanticipated, different, or worse symptoms might result and
53 that death could be hastened by the proposed treatment. The
54 description shall be based on the physician’s knowledge of the
55 efficacy of proposed treatment for the patient’s terminal
56 condition.
57 5. A statement that the patient’s health plan or third
58 party administrator and physician are not obligated to pay for
59 care or treatment consequent to the use of the investigational
60 drug, biological product, or device unless required to do so by
61 law or contract.
62 6. A statement that the patient’s eligibility for hospice
63 care may be withdrawn if the patient begins treatment with the
64 investigational drug, biological product, or device and that
65 hospice care may be reinstated if the treatment ends and the
66 patient meets hospice eligibility requirements.
67 7. A statement that the patient understands he or she is
68 liable for all expenses consequent to the use of the
69 investigational drug, biological product, or device and that
70 liability extends to the patient’s estate, unless a contract
71 between the patient and the manufacturer of the investigational
72 drug, biological product, or device states otherwise.
73 (3) Upon the request of an eligible patient, a manufacturer
74 may:
75 (a) Make its investigational drug, biological product, or
76 device available under this section.
77 (b) Provide an investigational drug, biological product, or
78 device to an eligible patient without receiving compensation.
79 (c) Require an eligible patient to pay the costs of, or the
80 costs associated with, the manufacture of the investigational
81 drug, biological product, or device.
82 (4) A health plan, third-party administrator, or
83 governmental agency may provide coverage for the cost of, or the
84 cost of services related to the use of, an investigational drug,
85 biological product, or device.
86 (5) A hospital or health care facility licensed under
87 chapter 395 is not required to provide new or additional
88 services unless those services are approved by the hospital or
89 health care facility.
90 (6) If an eligible patient dies while using an
91 investigational drug, biological product, or device pursuant to
92 this section, the patient’s heirs are not liable for any
93 outstanding debt related to the patient’s use of the
94 investigational drug, biological product, or device.
95 (7) A licensing board may not revoke, fail to renew,
96 suspend, or take any action against a physician’s license issued
97 under chapter 458 or chapter 459 based solely on the physician’s
98 recommendations to an eligible patient regarding access to or
99 treatment with an investigational drug, biological product, or
100 device. A state entity responsible for Medicare certification
101 may not take action against a physician’s Medicare certification
102 based solely on the physician’s recommendation that an eligible
103 patient have access to an investigational drug, biological
104 product, or device.
105 (8) This section does not create a private cause of action
106 against the manufacturer of an investigational drug, biological
107 product, or device; against a person or entity involved in the
108 care of an eligible patient who is using the investigational
109 drug, biological product, or device; or for any harm to the
110 eligible patient that is a result of the use of the
111 investigational drug, biological product, or device if the
112 manufacturer or other person or entity complies in good faith
113 with the terms of this section and exercises reasonable care.
114 (9) This section does not expand the coverage an insurer
115 must provide under the Florida Insurance Code and does not
116 affect mandatory health coverage for participation in clinical
117 trials.
118 Section 2. This act shall take effect July 1, 2015.
119
120 ================= T I T L E A M E N D M E N T ================
121 And the title is amended as follows:
122 Delete everything before the enacting clause
123 and insert:
124 A bill to be entitled
125 An act relating to experimental treatments for
126 terminal conditions; creating s. 499.0295, F.S.;
127 providing a short title; providing definitions;
128 providing conditions for a manufacturer to provide
129 certain drugs, products, or devices to an eligible
130 patient; specifying insurance coverage requirements
131 and exceptions; providing conditions for the provision
132 of certain services by a hospital or health care
133 facility; providing immunity from liability; providing
134 protection from disciplinary or legal action against a
135 physician who makes certain treatment recommendations;
136 providing that a cause of action may not be asserted
137 against the manufacturer of certain drugs, products,
138 or devices or a person or entity caring for a patient
139 using such drugs, products, or devices under certain
140 circumstances; providing applicability; providing an
141 effective date.